CTA Informed Consent Process 3 — Questions and Answers
Question 1: A sponsor-employed nurse conducts the informed consent discussion for a trial at an investigative site. What is the key concern with this arrangement?
- Nurses are not qualified to explain clinical trial procedures
- The participant may feel undue pressure to enroll because the nurse represents the entity funding the trial (Correct answer)
- It violates GCP because only physicians may obtain consent
- The sponsor nurse cannot be listed on the consent form as the person who explained the study
Correct answer: The participant may feel undue pressure to enroll because the nurse represents the entity funding the trial
Sponsor employees obtaining consent may create a conflict of interest and undue influence, as participants may feel obligated to enroll to please the funding source.
Question 2: What does the term 'capacity' mean in the context of informed consent?
- The physical ability of a participant to complete all study visits
- A participant's ability to understand information, appreciate its relevance, reason about options, and communicate a choice (Correct answer)
- The legal age threshold set by each state for medical decision-making
- The maximum number of participants a site is authorized to enroll
Correct answer: A participant's ability to understand information, appreciate its relevance, reason about options, and communicate a choice
Capacity refers to the cognitive and communicative ability to make an informed voluntary decision, distinct from legal competence.
Question 3: Under the ICH E6(R3) GCP guidelines, who is ultimately responsible for ensuring that informed consent is properly obtained?
- The IRB/IEC that approved the consent form
- The investigator (Correct answer)
- The sponsor's clinical research associate
- The regulatory authority that approved the trial
Correct answer: The investigator
ICH E6(R3) places ultimate responsibility on the investigator to ensure that informed consent is obtained before any trial-related procedures are conducted.
Question 4: A participant's cognitive status deteriorates during the trial and they can no longer provide ongoing consent. What is the appropriate next step?
- Continue the trial since initial consent was valid
- Seek consent from a legally authorized representative and assess whether continued participation is in the participant's best interest (Correct answer)
- Immediately withdraw the participant without further evaluation
- Transfer responsibility for consent to the participant's primary care physician
Correct answer: Seek consent from a legally authorized representative and assess whether continued participation is in the participant's best interest
When a participant loses capacity, a legally authorized representative must assume the consent role, and the ethical appropriateness of continued participation must be evaluated.
Question 5: Which of the following scenarios represents a breach of informed consent documentation requirements under FDA regulations?
- The consent form is printed in 12-point font
- The consent form is signed after a study-related blood draw has already been performed (Correct answer)
- The consent form includes a statement about compensation for injury
- The consent form is stored in a locked file cabinet at the site
Correct answer: The consent form is signed after a study-related blood draw has already been performed
Performing any study-related procedure before obtaining signed informed consent violates 21 CFR 50.20, which requires consent prior to trial participation.
Question 6: A participant asks whether they can withdraw from the study at any time. Which response is most accurate according to GCP?
- Withdrawal is allowed but requires a 30-day notice period per protocol
- Participants may withdraw at any time without penalty or loss of benefits to which they are otherwise entitled (Correct answer)
- Withdrawal is only permitted before the first dose of study drug is administered
- Participants may withdraw but must complete the end-of-study visit to do so
Correct answer: Participants may withdraw at any time without penalty or loss of benefits to which they are otherwise entitled
GCP and 21 CFR 50.25(a)(8) require that participants be informed they may withdraw at any time without penalty or loss of otherwise entitled benefits.
Question 7: What is the purpose of including a statement about confidentiality limits in the informed consent form?
- To warn participants that their data may be sold to third-party marketers
- To inform participants that regulatory authorities and sponsors may inspect records, limiting absolute confidentiality (Correct answer)
- To notify participants that their physician will receive all study results
- To satisfy insurance company requirements for trial coverage
Correct answer: To inform participants that regulatory authorities and sponsors may inspect records, limiting absolute confidentiality
Participants must be told that while confidentiality will be maintained, records may be inspected by the FDA, sponsor, and IRB, so absolute privacy cannot be guaranteed.
CTA Informed Consent Process 3
A sponsor-employed nurse conducts the informed consent discussion for a trial at an investigative site.
What is the key concern with this arrangement?